International consensus to define outcomes for trials of chemoradiotherapy for anal cancer (CORMAC-2): defining the outcomes from the CORMAC core outcome set

Summary: Variation in outcomes definitions and reporting limit the utility of clinical trial results. The Core Outcome Research Measures in Anal Cancer (CORMAC) project developed a core outcome set (COS) for chemoradiotherapy trials for anal squamous cell carcinoma (ASCC) through an international he...

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Main Authors: Robert Samuel, Stephen R. Knight, Richard Adams, Prajnan Das, Jennifer Dorth, David Finch, Marianne G. Guren, Maria A. Hawkins, Susan Moug, Lakshmi Rajdev, David Sebag-Montefiore, Andrew G. Renehan, Rebecca Fish, Miguel A. Rodriguez-Bigas, Pratik Adusumilli, Ahmed Allam Mohamed, Mario Alvarez Gallego, Eva Angenete, Ane Appelt, Maaike Berbee, Danielle Brogden, Peter Brown, Lucy Buckley, Nathalie Casanova, Rachel Cooper, Nuno Couto, Peter Coyne, Tamzin Cuming, Charlotte Deijin, Kristopher Dennis, Cathy Eng, Alexandra Gilbert, Duncan Gilbert, Karyn Goodman, Rashmi Jadon, Anders Johnsson, Arunansu Kar, Ethan Ludmir, Marie-Louise Lydrup, Ivan Lyra-Gonzalez, Stefania Manfrida, Rebecca Muirhead, Sarah O'Dwyer, Thomas Rackley, Lukasz Raszewski, Leslie Samuel, Mark Saunders, Andrew Scarsbrook, Eva Segelov, Timothy Simmons, Paul Sutton, Nicholas Symons, Deborah Williamson
Format: Article
Language:English
Published: Elsevier 2024-12-01
Series:EClinicalMedicine
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Online Access:http://www.sciencedirect.com/science/article/pii/S2589537024005182
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author Robert Samuel
Stephen R. Knight
Richard Adams
Prajnan Das
Jennifer Dorth
David Finch
Marianne G. Guren
Maria A. Hawkins
Susan Moug
Lakshmi Rajdev
David Sebag-Montefiore
Andrew G. Renehan
Rebecca Fish
Miguel A. Rodriguez-Bigas
Pratik Adusumilli
Ahmed Allam Mohamed
Mario Alvarez Gallego
Eva Angenete
Ane Appelt
Maaike Berbee
Danielle Brogden
Peter Brown
Lucy Buckley
Nathalie Casanova
Rachel Cooper
Nuno Couto
Peter Coyne
Tamzin Cuming
Charlotte Deijin
Kristopher Dennis
Cathy Eng
Alexandra Gilbert
Duncan Gilbert
Karyn Goodman
Rashmi Jadon
Anders Johnsson
Arunansu Kar
Ethan Ludmir
Marie-Louise Lydrup
Ivan Lyra-Gonzalez
Stefania Manfrida
Rebecca Muirhead
Sarah O'Dwyer
Thomas Rackley
Lukasz Raszewski
Leslie Samuel
Mark Saunders
Andrew Scarsbrook
Eva Segelov
Timothy Simmons
Paul Sutton
Nicholas Symons
Deborah Williamson
author_facet Robert Samuel
Stephen R. Knight
Richard Adams
Prajnan Das
Jennifer Dorth
David Finch
Marianne G. Guren
Maria A. Hawkins
Susan Moug
Lakshmi Rajdev
David Sebag-Montefiore
Andrew G. Renehan
Rebecca Fish
Miguel A. Rodriguez-Bigas
Pratik Adusumilli
Ahmed Allam Mohamed
Mario Alvarez Gallego
Eva Angenete
Ane Appelt
Maaike Berbee
Danielle Brogden
Peter Brown
Lucy Buckley
Nathalie Casanova
Rachel Cooper
Nuno Couto
Peter Coyne
Tamzin Cuming
Charlotte Deijin
Kristopher Dennis
Cathy Eng
Alexandra Gilbert
Duncan Gilbert
Karyn Goodman
Rashmi Jadon
Anders Johnsson
Arunansu Kar
Ethan Ludmir
Marie-Louise Lydrup
Ivan Lyra-Gonzalez
Stefania Manfrida
Rebecca Muirhead
Sarah O'Dwyer
Thomas Rackley
Lukasz Raszewski
Leslie Samuel
Mark Saunders
Andrew Scarsbrook
Eva Segelov
Timothy Simmons
Paul Sutton
Nicholas Symons
Deborah Williamson
author_sort Robert Samuel
collection DOAJ
description Summary: Variation in outcomes definitions and reporting limit the utility of clinical trial results. The Core Outcome Research Measures in Anal Cancer (CORMAC) project developed a core outcome set (COS) for chemoradiotherapy trials for anal squamous cell carcinoma (ASCC) through an international healthcare professional and patient consensus process. The CORMAC-COS comprises 19 outcomes across 4 domains (disease activity, survival, toxicity, life impact). In CORMAC-2 we have established standardised definitions for the 11 disease activity and survival outcomes in the CORMAC COS. Definitions were agreed through a 3 step process, initially identifying existing definitions through systematic review (registered with PROSPERO, CRD42016036540), using these to populate a two-round Delphi questionnaire completed by 51 experts from 13 countries, and finally ratification through an online consensus meeting. Standardising the definitions for these core outcomes facilitates real world utilisation of the CORMAC-COS, thereby increasing the quality of data available for clinical decision-making and ultimately enhancing patient care.
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spelling doaj-art-13141decd4db43eeae1e82431775d0e82024-12-07T08:28:12ZengElsevierEClinicalMedicine2589-53702024-12-0178102939International consensus to define outcomes for trials of chemoradiotherapy for anal cancer (CORMAC-2): defining the outcomes from the CORMAC core outcome setRobert Samuel0Stephen R. Knight1Richard Adams2Prajnan Das3Jennifer Dorth4David Finch5Marianne G. Guren6Maria A. Hawkins7Susan Moug8Lakshmi Rajdev9David Sebag-Montefiore10Andrew G. Renehan11Rebecca Fish12Miguel A. Rodriguez-BigasPratik AdusumilliAhmed Allam MohamedMario Alvarez GallegoEva AngeneteAne AppeltMaaike BerbeeDanielle BrogdenPeter BrownLucy BuckleyNathalie CasanovaRachel CooperNuno CoutoPeter CoyneTamzin CumingCharlotte DeijinKristopher DennisCathy EngAlexandra GilbertDuncan GilbertKaryn GoodmanRashmi JadonAnders JohnssonArunansu KarEthan LudmirMarie-Louise LydrupIvan Lyra-GonzalezStefania ManfridaRebecca MuirheadSarah O'DwyerThomas RackleyLukasz RaszewskiLeslie SamuelMark SaundersAndrew ScarsbrookEva SegelovTimothy SimmonsPaul SuttonNicholas SymonsDeborah WilliamsonNIHR Manchester Biomedical Research Centre, Division of Cancer Sciences, School of Medical Sciences, Faculty of Biology Medicine and Health, University of Manchester, Manchester, UK; University of Leeds, Leeds Institute for Medical Research, St. James's University Hospital, Leeds, UKCentre for Medical Informatics, Usher Institute, University of Edinburgh, Edinburgh, UK; School of Health and Wellbeing, University of Glasgow, Glasgow, UKCentre for Trials Research, Cardiff University School of Medicine, Cardiff, UKUniversity of Texas MD Anderson Cancer Center, USADepartment of Radiation Oncology, University Hospitals Cleveland Medical Centre, Cleveland, USANIHR Manchester Biomedical Research Centre, Division of Cancer Sciences, School of Medical Sciences, Faculty of Biology Medicine and Health, University of Manchester, Manchester, UK; Colorectal and Peritoneal Oncology Centre, The Christie NHS FT, ManchesterDepartment of Oncology, Oslo University Hospital, Institute of Clinical Medicine, University of Oslo, Oslo, NorwayDepartment of Medical Physics and Biomedical Engineering, University College London, London, UKDepartment of Colorectal Surgery, Royal Alexandra Hospital, Paisley, UKTisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USAUniversity of Leeds, Leeds Institute for Medical Research, St. James's University Hospital, Leeds, UKNIHR Manchester Biomedical Research Centre, Division of Cancer Sciences, School of Medical Sciences, Faculty of Biology Medicine and Health, University of Manchester, Manchester, UK; Colorectal and Peritoneal Oncology Centre, The Christie NHS FT, ManchesterNIHR Manchester Biomedical Research Centre, Division of Cancer Sciences, School of Medical Sciences, Faculty of Biology Medicine and Health, University of Manchester, Manchester, UK; Colorectal and Peritoneal Oncology Centre, The Christie NHS FT, Manchester; Corresponding author. NIHR Manchester Biomedical Research Centre, Division of Cancer Sciences, School of Medical Sciences, Faculty of Biology Medicine and Health, University of Manchester, Manchester, UK.Summary: Variation in outcomes definitions and reporting limit the utility of clinical trial results. The Core Outcome Research Measures in Anal Cancer (CORMAC) project developed a core outcome set (COS) for chemoradiotherapy trials for anal squamous cell carcinoma (ASCC) through an international healthcare professional and patient consensus process. The CORMAC-COS comprises 19 outcomes across 4 domains (disease activity, survival, toxicity, life impact). In CORMAC-2 we have established standardised definitions for the 11 disease activity and survival outcomes in the CORMAC COS. Definitions were agreed through a 3 step process, initially identifying existing definitions through systematic review (registered with PROSPERO, CRD42016036540), using these to populate a two-round Delphi questionnaire completed by 51 experts from 13 countries, and finally ratification through an online consensus meeting. Standardising the definitions for these core outcomes facilitates real world utilisation of the CORMAC-COS, thereby increasing the quality of data available for clinical decision-making and ultimately enhancing patient care.http://www.sciencedirect.com/science/article/pii/S2589537024005182Core outcome setOutcomesAnal cancerConsensusDelphiChemoradiotherapy
spellingShingle Robert Samuel
Stephen R. Knight
Richard Adams
Prajnan Das
Jennifer Dorth
David Finch
Marianne G. Guren
Maria A. Hawkins
Susan Moug
Lakshmi Rajdev
David Sebag-Montefiore
Andrew G. Renehan
Rebecca Fish
Miguel A. Rodriguez-Bigas
Pratik Adusumilli
Ahmed Allam Mohamed
Mario Alvarez Gallego
Eva Angenete
Ane Appelt
Maaike Berbee
Danielle Brogden
Peter Brown
Lucy Buckley
Nathalie Casanova
Rachel Cooper
Nuno Couto
Peter Coyne
Tamzin Cuming
Charlotte Deijin
Kristopher Dennis
Cathy Eng
Alexandra Gilbert
Duncan Gilbert
Karyn Goodman
Rashmi Jadon
Anders Johnsson
Arunansu Kar
Ethan Ludmir
Marie-Louise Lydrup
Ivan Lyra-Gonzalez
Stefania Manfrida
Rebecca Muirhead
Sarah O'Dwyer
Thomas Rackley
Lukasz Raszewski
Leslie Samuel
Mark Saunders
Andrew Scarsbrook
Eva Segelov
Timothy Simmons
Paul Sutton
Nicholas Symons
Deborah Williamson
International consensus to define outcomes for trials of chemoradiotherapy for anal cancer (CORMAC-2): defining the outcomes from the CORMAC core outcome set
EClinicalMedicine
Core outcome set
Outcomes
Anal cancer
Consensus
Delphi
Chemoradiotherapy
title International consensus to define outcomes for trials of chemoradiotherapy for anal cancer (CORMAC-2): defining the outcomes from the CORMAC core outcome set
title_full International consensus to define outcomes for trials of chemoradiotherapy for anal cancer (CORMAC-2): defining the outcomes from the CORMAC core outcome set
title_fullStr International consensus to define outcomes for trials of chemoradiotherapy for anal cancer (CORMAC-2): defining the outcomes from the CORMAC core outcome set
title_full_unstemmed International consensus to define outcomes for trials of chemoradiotherapy for anal cancer (CORMAC-2): defining the outcomes from the CORMAC core outcome set
title_short International consensus to define outcomes for trials of chemoradiotherapy for anal cancer (CORMAC-2): defining the outcomes from the CORMAC core outcome set
title_sort international consensus to define outcomes for trials of chemoradiotherapy for anal cancer cormac 2 defining the outcomes from the cormac core outcome set
topic Core outcome set
Outcomes
Anal cancer
Consensus
Delphi
Chemoradiotherapy
url http://www.sciencedirect.com/science/article/pii/S2589537024005182
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